Hemorrhagic SyndromeSEROTSTGNCT07302087
Platelet Serotonin Deficiencies: the Strasbourg Experience
An observational study of Hemorrhagic Syndrome, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Hemorrhagic syndromes are investigated using algorithms established by reference centers and hemostasis societies. The investigation of platelet dense granules (nucleotide and serotonin testing) is part of the second-line tests. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhagic Syndrome
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2024to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient (≥ 18 years old) treated at Strasbourg University Hospital for a hemorrhagic syndrome, suggesting a primary hemostasis abnormality and normal von Willebrand factor, during the period from January 1, 2023, to April 1, 2024.
Who may be able to join
- Adult patient (≥ 18 years old)
- Treated at Strasbourg University Hospital for a hemorrhagic syndrome, suggesting a primary hemostasis abnormality and normal von Willebrand factor, during the period from January 1, 2023, to April 1, 2024.
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de Ressources et de Compétences des Maladies Hémorragiques Constitutionnelles - CHU de Strasbourg - France
Strasbourg, 67091
Dominique Desprez, MD, 33 3 88 12 83 71, dominique.desprez@chru-strasbourg.fr
Dominique Desprez, MD
About this study
Hemorrhagic syndromes are investigated using algorithms established by reference centers and hemostasis societies.
The investigation of platelet dense granules (nucleotide and serotonin testing) is part of the second-line tests.
Read more
It can be performed in cases of platelet aggregation abnormalities in platelet-rich plasma (PRP) suggesting a secretion abnormality, or in cases where the latter is normal, it can be performed if the patient's clinical presentation points to a primary hemostasis abnormality and the clinician wishes to pursue further investigations Intraplatelet serotonin deficiencies are often iatrogenic and may be accompanied by bleeding.
Their impact on platelet function is poorly documented.
- Conditions
- Hemorrhagic Syndrome
- Keywords
- Hemorrhagic syndrome, Serotonin deficiencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of ISTH BAT Hemorrhagic Questionnaire
ISTH BAT bleeding questionnaire with its 12-item grid scored from 0 to 4:
A score ≥ 4 in men or ≥ 6 in women makes the presence of a constitutional hemostasis disorder highly probable
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start25 Nov 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302087
- Sponsor's protocol ID
- 9484
- Acronym
- SEROTSTG
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Serotonin Deficiencies: the Strasbourg Experience
- ClinicalTrials.gov ID
- NCT07302087
- Acronym / sponsor ID
- SEROTSTG / 9484
- Conditions
- Hemorrhagic Syndrome
- Keywords
- Hemorrhagic syndrome, Serotonin deficiencies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemorrhagic syndromes are investigated using algorithms established by reference centers and hemostasis societies.
The investigation of platelet dense granules (nucleotide and serotonin testing) is part of the second-line tests.
It can be performed in cases of platelet aggregation abnormalities in platelet-rich plasma (PRP) suggesting a secretion abnormality, or in cases where the latter is normal, it can be performed if the patient's clinical presentation points to a primary hemostasis abnormality and the clinician wishes to pursue further investigations Intraplatelet serotonin deficiencies are often iatrogenic and may be accompanied by bleeding.
Their impact on platelet function is poorly documented.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥ 18 years old) treated at Strasbourg University Hospital for a hemorrhagic syndrome, suggesting a primary hemostasis abnormality and normal von Willebrand factor, during the period from January 1, 2023, to April 1, 2024.
Key inclusion criteria (2 listed)
- Adult patient (≥ 18 years old)
- Treated at Strasbourg University Hospital for a hemorrhagic syndrome, suggesting a primary hemostasis abnormality and normal von Willebrand factor, during the period from January 1, 2023, to April 1, 2024.
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Score of ISTH BAT Hemorrhagic Questionnaire
Time frame: Up to 12 months
ISTH BAT bleeding questionnaire with its 12-item grid scored from 0 to 4: A score ≥ 4 in men or ≥ 6 in women makes the presence of a constitutional hemostasis disorder highly probable
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhagic Syndrome, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique DESPREZ, MD (33 3 88 12 83 71, dominique.desprez@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of ISTH BAT Hemorrhagic Questionnaire (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.